長期使用質子幫浦抑制劑會增加髖骨骨折風險


  【24drs.com】一篇新研究強調,長期使用質子幫浦抑制劑(PPIs)會增加停經後婦女的髖骨骨折風險,特別是有抽菸者。
  
  PPIs會增加胃泌素之分泌、抑制鈣質吸收、改變破骨細胞功能而影響骨折風險,美國自2003年後,這些藥物就可以開架式販售,用來治療消化不良,到了2010年5月,美國食品藥物管理局提出警訊,廣泛使用PPI和髖骨骨折有所關聯,要求提供進一步的資訊。
  
  線上登載於1月31日英國醫學期刊上的新研究發表了近80,000名婦女的資料,波士頓麻州綜合醫院Hamed Khalili醫師等人檢視了「護士健康研究」這項研究的前瞻世代資料,該研究提供了生活型態與飲食風險因素的資訊;這項研究始於1982年,每2年以問卷方式評估研究對象。
  
  該研究的79,899名婦女研究對象中,PPIs使用情況在2000-2008年間增加將近3倍,從6.7%增至18.9%;研究者在追蹤的565,786人-年之間共發現有893例髖骨骨折。長期使用這類藥物至少2年的婦女,髖骨骨折的絕對風險是每1000人-年為2.02件,沒有使用這類藥物的婦女則是每1000人-年為1.51件。
  
  使用PPIs 2年以上的婦女,髖骨骨折風險高出35%(年齡校正風險比為1.35;95%信心區間[CI]為1.13 - 1.62),校正身體質量指數、體能活動情況、鈣質攝取、使用其他可能影響骨折風險的藥物(例如雙磷酸鹽類、thiazide類利尿劑、皮質類固醇、荷爾蒙替代療法)等之後,關聯依舊成立。
  
  長期使用PPI與髖骨骨折風險有關。研究者報告指出,相較於未使用這類藥物者,使用PPIs 2年的婦女發生骨折的完整校正風險比為1.36 (1.12 - 1.65)、使用4年者為1.42 (1.05 - 1.93)、使用6-8年者為1.55 (1.03 - 2.32),不過,停止服用這類藥物至少2年後,風險值恢復到正常。
  
  抽菸史在考慮的風險因素中佔首位,目前有抽菸或曾經抽菸婦女的骨折風險增加超過50% (完整校正風險比為1.51 [95% CI,1.20 - 1.91]),相對的,作者們發現從未抽菸者使用PPI和骨折風險並無關聯(完整校正風險比為1.06 [95% CI,0.77 - 1.46]),研究者認為,抽菸會抑制鈣質吸收,因而加重了PPIs增加骨折的風險,而使用PPI的原因並不會影響骨折風險。
  
  根據研究者指出,研究強度包括:前瞻式設計、樣本數多、分析了幾個公認的可能風險因素,研究限制是,未載明PPIs的品牌與計量;研究者結論指出,停經後婦女長期使用PPI與髖骨骨折風險增加有關,使用期間最久者或是有抽菸史的婦女,其風險最大。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6718&x_classno=0&x_chkdelpoint=Y
  

Proton Pump Inhibitors Raise Hip Fracture Risk Over Time

By Ricki Lewis, PhD
Medscape Medical News

January 31, 2012 — A new study strengthens the association of long-term use of proton pump inhibitors (PPIs) with increased risk for hip fracture in postmenopausal women, particularly those who smoke.

PPIs can affect fracture risk by increasing secretion of gastrin, inhibiting calcium absorption, and altering osteoclast function. Use of these drugs to treat indigestion increased when they became available over the counter in the United States in 2003. In May 2010, the US Food and Drug Administration issued a warning about the possible link between extended PPI use and hip fracture and requested further information.

The new study, published online January 31 in the British Medical Journal, adds information from nearly 80,000 women to the body of data. Hamed Khalili, MD, from Massachusetts General Hospital, Boston, Massachusetts, and colleagues examined data from the prospective cohort Nurses' Health Study, which provided information on lifestyle and dietary risk factors. The study, which began in 1982, assesses participants by questionnaire every 2 years.

Use of PPIs increased nearly 3-fold from 2000 to 2008 among the 79,899 women in the study, from 6.7% to 18.9%. The researchers documented 893 hip fractures over 565,786 person-years of follow-up. Absolute risk for hip fracture among the women who regularly used the drugs for at least 2 years was 2.02 events per 1000 person years compared with 1.51 events per 1000 person years among women who did not take the drugs.

The risk for hip fracture among women who used PPIs for 2 or more years was 35% higher (age-adjusted hazard ratio, 1.35; 95% confidence interval [CI], 1.13 - 1.62). The association held up after adjusting for body mass index, physical activity level, calcium intake, and use of other drugs that can affect fracture risk, such as bisphosphonates, thiazide diuretics, corticosteroids, and hormone replacement.

Hip fracture risk correlated with PPI use over time. "Compared with non-users, the fully adjusted hazard ratios of fracture were 1.36 (1.12 - 1.65) for women with two years' use of PPIs, 1.42 (1.05 - 1.93) for four years' use, and 1.55 (1.03 - 2.32) for six to eight years' use," the researchers report. However, the risk returns to normal for women who have ceased taking the drugs for at least 2 years.

Smoking history stood out among the risk factors considered. Fracture risk rose by more than 50% for women who currently smoke or did so previously (fully-adjusted hazard ratio 1.51 [95% CI, 1.20 - 1.91]). By contrast, the authors found no association between PPI use and fracture risk in never smokers (fully-adjusted hazard ratio 1.06 [95% CI, 0.77 - 1.46]). The researchers suggest that the inhibition of calcium absorption from smoking may act synergistically with PPIs to increase fracture risk. The reason for PPI use did not affect fracture risk.

Strengths of the study, according to the investigators, include its prospective design, large sample, and analysis of several putative confounding risk factors. A limitation is that the study did not include brands and dosages of the PPIs. The researchers conclude that "regular use of PPI was associated with increased risk of hip fracture among postmenopausal women, with the strongest risk observed in individuals with the longest duration of use or with a history of smoking."

The authors have disclosed no relevant financial relationships.

BMJ. Published online January 31, 2012.

    
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